drugset / Trial / NCT00442611

A Study to Evaluate the Safety and Efficacy of Abatacept in Patients With Diffuse Systemic Sclerosis (Scleroderma)

NCT00442611 ↗

Phase 1/2 Completed 10 enrolled Stanford University Bristol-Myers Squibb · collab
RandomizedParallel-groupTriple-blindTreatment

Summary

Systemic sclerosis (scleroderma) is an autoimmune connective tissue disease that involves the skin and other internal organs for which there are few effective treatment options. We hypothesize that treatment with abatacept, a new therapy recently approved for the treatment of rheumatoid arthritis, may reduce the progression of skin thickening and fibrosis in people with scleroderma.

Timeline

Start
2008-11
Primary completion
2011-06
Completion
2011-06

Outcome

Met primary endpoint

paper After adjusting for disease duration, mRSS significantly improved in the abatacept compared with the placebo group PMID 26071192 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Abatacept Other / unclassified — Intravenous